A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

NCT03928743 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: AS00112017-003065-95
• Study Type: interventional
• Target: 332
• Locations: 14 countries
• Sites: 83

Brief Summary

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis; AS; Bimekizumab; Axial spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 16

  ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA) assessed disease activity on a scale of 0 \[not active\] to 10 \[very active\], higher score=more disease activity, Pain assessment on a scale of 0 \[no pain\] to 10 \[most severe pain\], higher score=more severity, Function (Bath Ankylosing Spondylitis Functional Index (BASFI)) assessed participant's level of ability on a scale of 0 \[easy\] to 10 \[impossible\], Inflammation (morning stiffness intensity and duration, mean of Q5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) defined as 6 item questionnaire: measured disease activity on a scale of 0 \[none\] to 10 \[severe\], higher score=more disease activity) and no worsening at all in the remaining domain.

  Week 16

Secondary Outcomes (16)

• Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response in TNFα Inhibitor-naïve Participants at Week 16

  Week 16

• Percentage of Participants With Assessment of SpondyloArthritis International Society 20% Response Criteria (ASAS20) Response at Week 16

  Week 16

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Week 16

  Baseline, Week 16

• Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) at Week 16

  Week 16

• Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) at Week 16

  Week 16

Study Arms (2)

Bimekizumab

EXPERIMENTAL

Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.

Drug: Bimekizumab

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.

Drug: Bimekizumab; Other: Placebo

Interventions

Bimekizumab DRUG

Subjects will receive bimekizumab at pre-specified time-points.

Also known as: BKZ, UCB4940

Bimekizumab; Placebo

Placebo OTHER

Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.

Also known as: PBO

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients at least 18 years of age
• Subject has ankylosing spondylitis (AS) as per the Modified New York (mNY) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years
• Subjects has moderate-to-severe active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>=4 AND spinal pain \>=4 on a 0 to 10 Numeric Rating Scale
• Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy
• Patients who have taken a tumor necrosis factor alpha (TNFα) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks
• Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

You may not qualify if:

• Total ankylosis of the spine
• Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα biological response modifiers, or any interleukin (IL)-17 biological response modifier at any time are excluded
• Active infection or history of recent serious infections
• Viral hepatitis B or C or human immunodeficiency virus (HIV) infection
• Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study
• Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection
• Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer
• Diagnosis of inflammatory conditions other than AxSpA, eg, rheumatoid arthritis. Patients with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study.
• Presence of active suicidal ideation, or moderately severe major depression or severe major depression
• Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study
• Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (83)

As0011 50131

Mesa, Arizona, 85210, United States

Location

As0011 50052

Phoenix, Arizona, 85032, United States

Location

As0011 50058

Phoenix, Arizona, 85037, United States

Location

As0011 50062

Sun City, Arizona, 85351, United States

Location

As0011 50060

Upland, California, 91786, United States

Location

As0011 50056

Sarasota, Florida, 34239, United States

Location

As0011 50015

Hagerstown, Maryland, 21740, United States

Location

As0011 50016

St Louis, Missouri, 63141, United States

Location

As0011 50054

Oklahoma City, Oklahoma, 73103, United States

Location

As0011 50020

Duncansville, Pennsylvania, 16635, United States

Location

As0011 50001

Jackson, Tennessee, 38305, United States

Location

As0011 50012

Memphis, Tennessee, 38119, United States

Location

As0011 50057

Dallas, Texas, 75231, United States

Location

As0011 50036

Mesquite, Texas, 75150, United States

Location

As0011 40004

Brussels, Belgium

Location

As0011 40003

Genk, Belgium

Location

As0011 40001

Ghent, Belgium

Location

As0011 40006

Plovdiv, Bulgaria

Location

As0011 40007

Plovdiv, Bulgaria

Location

As0011 40005

Sofia, Bulgaria

Location

As0011 40008

Sofia, Bulgaria

Location

As0011 20040

Beijing, China

Location

As0011 20021

Chengdu, China

Location

As0011 20019

Guangzhou, China

Location

As0011 20034

Hefei, China

Location

As0011 20024

Nanjing, China

Location

As0011 20018

Shanghai, China

Location

As0011 20020

Shanghai, China

Location

As0011 20026

Shanghai, China

Location

As0011 20025

Wenzhou, China

Location

As0011 40011

Brno, Czechia

Location

As0011 40009

Pardubice, Czechia

Location

As0011 40013

Prague, Czechia

Location

As0011 40014

Prague, Czechia

Location

As0011 40015

Prague, Czechia

Location

As0011 40016

Prague, Czechia

Location

As0011 40010

Uherské Hradiště, Czechia

Location

As0011 40012

Zlín, Czechia

Location

As0011 40018

Boulogne-Billancourt, France

Location

As0011 40022

Limoges, France

Location

As0011 40025

Berlin, Germany

Location

As0011 40028

Berlin, Germany

Location

As0011 40029

Hamburg, Germany

Location

As0011 40024

Hanover, Germany

Location

As0011 40027

Herne, Germany

Location

As0011 40078

Leipzig, Germany

Location

As0011 40026

Ratingen, Germany

Location

As0011 40032

Debrecen, Hungary

Location

As0011 40031

Szeged, Hungary

Location

As0011 40033

Székesfehérvár, Hungary

Location

As0011 40080

Szombathely, Hungary

Location

As0011 20030

Chūōku, Japan

Location

As0011 20047

Himeji-shi, Japan

Location

As0011 20045

Kita-gun, Japan

Location

As0011 20065

Kitakyushu, Japan

Location

As0011 20037

Osaka, Japan

Location

As0011 20084

Saga, Japan

Location

As0011 20048

Saitama, Japan

Location

As0011 20031

Sapporo, Japan

Location

As0011 20042

Sasebo, Japan

Location

As0011 20032

Suita, Japan

Location

As0011 20035

Tokyo, Japan

Location

As0011 40034

Amsterdam, Netherlands

Location

As0011 40038

Elblag, Poland

Location

As0011 40042

Krakow, Poland

Location

As0011 40037

Lublin, Poland

Location

As0011 40044

Poznan, Poland

Location

As0011 40040

Torun, Poland

Location

As0011 40041

Warsaw, Poland

Location

As0011 40039

Wroclaw, Poland

Location

As0011 40043

Wroclaw, Poland

Location

As0011 40045

A Coruña, Spain

Location

As0011 40046

Córdoba, Spain

Location

As0011 40047

Madrid, Spain

Location

As0011 40048

Santiago de Compostela, Spain

Location

As0011 40049

Seville, Spain

Location

As0011 40052

Ankara, Turkey (Türkiye)

Location

As0011 40053

Ankara, Turkey (Türkiye)

Location

As0011 40050

Istanbul, Turkey (Türkiye)

Location

As0011 40057

Edinburgh, United Kingdom

Location

As0011 40056

Leeds, United Kingdom

Location

As0011 40054

London, United Kingdom

Location

As0011 40055

Norwich, United Kingdom

Location

Related Publications (10)

• van der Heijde D, Deodhar A, Baraliakos X, Brown MA, Dobashi H, Dougados M, Elewaut D, Ellis AM, Fleurinck C, Gaffney K, Gensler LS, Haroon N, Magrey M, Maksymowych WP, Marten A, Massow U, Oortgiesen M, Poddubnyy D, Rudwaleit M, Shepherd-Smith J, Tomita T, Van den Bosch F, Vaux T, Xu H. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis. 2023 Apr;82(4):515-526. doi: 10.1136/ard-2022-223595. Epub 2023 Jan 17.

  PMID: 36649967 RESULT

• Navarro-Compan V, Ramiro S, Deodhar A, Mease PJ, Rudwaleit M, de la Loge C, Fleurinck C, Taieb V, Morup MF, Massow U, Kay J, Magrey M. Association of clinical response criteria and disease activity levels with axial spondyloarthritis core domains: results from two phase 3 randomised studies, BE MOBILE 1 and 2. RMD Open. 2024 Apr 10;10(2):e004040. doi: 10.1136/rmdopen-2023-004040.

  PMID: 38599650 RESULT

• Dubreuil M, Navarro-Compan V, Boonen A, Gaffney K, Gensler LS, de la Loge C, Vaux T, Fleurinck C, Massow U, Taieb V, Morup MF, Deodhar A, Rudwaleit M. Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies. RMD Open. 2024 Jun 4;10(2):e004202. doi: 10.1136/rmdopen-2024-004202.

  PMID: 38834351 RESULT

• Ramiro S, Poddubnyy D, Mease PJ, Lopez-Medina C, Kim M, Massow U, Taieb V, Kragstrup TW, McGonagle D. Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis. RMD Open. 2025 Oct 22;11(4):e005969. doi: 10.1136/rmdopen-2025-005969.

  PMID: 41125403 RESULT

• Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.

  PMID: 41807031 DERIVED

• Marzo-Ortega H, Navarro-Compan V, Dubreuil M, Mease PJ, Magrey M, Rudwaleit M, D'Agostino MA, Gaffney K, Kay J, de la Loge C, Massow U, Taieb V, Vaux T, Deodhar A. Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies. RMD Open. 2025 Nov 28;11(4):e006013. doi: 10.1136/rmdopen-2025-006013.

  PMID: 41314667 DERIVED

• Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.

  PMID: 40194794 DERIVED

• Navarro-Compan V, Rudwaleit M, Dubreuil M, Magrey M, Marzo-Ortega H, Mease PJ, Walsh JA, Dougados M, de la Loge C, Fleurinck C, Massow U, Vaux T, Taieb V, Deodhar A. Improved Pain, Morning Stiffness, and Fatigue With Bimekizumab in Axial Spondyloarthritis: Results From the Phase III BE MOBILE Studies. J Rheumatol. 2025 Jan 1;52(1):23-32. doi: 10.3899/jrheum.2024-0223.

  PMID: 39406403 DERIVED

• Cella D, de la Loge C, Fofana F, Guo S, Ellis A, Fleurinck C, Massow U, Dougados M, Navarro-Compan V, Walsh JA. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation. J Patient Rep Outcomes. 2024 Aug 12;8(1):92. doi: 10.1186/s41687-024-00769-x.

  PMID: 39133438 DERIVED

• Baraliakos X, Deodhar A, van der Heijde D, Magrey M, Maksymowych WP, Tomita T, Xu H, Massow U, Fleurinck C, Ellis AM, Vaux T, Shepherd-Smith J, Marten A, Gensler LS. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Ann Rheum Dis. 2024 Jan 11;83(2):199-213. doi: 10.1136/ard-2023-224803.

  PMID: 37793792 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 26, 2019
• Study Start: April 25, 2019
• Primary Completion: September 3, 2021
• Study Completion: August 8, 2022
• Last Updated: December 24, 2025
• Results First Posted: October 10, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

JP (11); PL (8); ES (5); GB (4); BE (3); DE (7); FR (2); CN (9); NL (1); TU (3); BU (4); US (14); CZ (8); HU (4)